SiteSeer™ 4A0025Recalls & reported problems
Medtronic, Inc. · CATH 4A0025 SS 10PK 4F STR TR PTAIL 125 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994851161), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
A SITESEER CATHETER WAS INTENDED TO BE USED TO TREAT A NON-CALCIFIED LESION IN THE AORTA. THE DEVICE WAS INTENDED TO REACH THE AORTA TO THE VALVE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. DEVICE REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. DEVICE WAS NOT INSPECTED. DEVICE WAS PREPPED WITH NO ISSUES. RESISTANCE WAS EXPERIENCED DURING USE, DURING DELIVERY TO THE TARGET LESION. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY.IT IS REPORTED THAT THE DEVICE COULD NOT CROSS THE ELBOW, SO THE PHYSICIAN TRIED TO PULL IT BACK. THE TIP OF THE DEVICE THEN DETACHED IN THE FOREARM, AND REMAINED IN THE RADIAL ARTERY. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THE PATIENT WAS THEN PUT IN SURGERY.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8226112 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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